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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K080678
Device Name UNI-KNEE 2.0
Applicant
Brainlab AG
Kapellenstrasse 12
Feldkirchen,  DE 85622
Applicant Contact PER PERSSON
Correspondent
Brainlab AG
Kapellenstrasse 12
Feldkirchen,  DE 85622
Correspondent Contact PER PERSSON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/10/2008
Decision Date 06/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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